The primary objective of this study is to demonstrate the effect of consuming daily 5 grams of Agaricus bisporus powder (10 capsules) on the vaccination response to an influenza vaccine in men and women aged 60 years or older during the influenza…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
verminderde immuunrespons
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the vaccination response to an influenza vaccine.
Secondary outcome
Secondary endpoints include amongst others, hematological, inflammatory and
immunological parameters (e.g. hs-CRP, leukocyte differential count, cytokines)
and metabolic markers (e.g. blood lipid profiles, plasma glucose).
Background summary
There are numerous in vitro and animal studies that suggested that mushrooms
beneficially influence the immune system. We have recently shown that a wild
isolate of the edible Agaricus bisporus mushroom had a clear effect on
parameters reflecting a better function of the immune system, both in vitro and
in vivo in animals. The question now is whether this efficacy can also be
translated to humans. In humans, measuring the antibody response is the golden
standard to evaluate immune function. It has been shown previously that higher
BMI and age are both negatively associated to vaccination responses. If
mushrooms indeed have beneficial effect on the immune system, people with
overweight or obesity and higher age might benefit from consuming mushrooms
prior to receiving the influenza vaccination.
Study objective
The primary objective of this study is to demonstrate the effect of consuming
daily 5 grams of Agaricus bisporus powder (10 capsules) on the vaccination
response to an influenza vaccine in men and women aged 60 years or older during
the influenza vaccination period 2023/2024.
Study design
A double-blind, randomized, placebo-controlled trial will be carried out. The
intervention period lasts approximately 8 weeks. After this, around May first
2024, a questionnaire about influenza related symptoms will be filled out by
the participants.
Intervention
The intervention group will receive 10 capsules daily containing Agaricus
bisporus powder to reach a required dose of 5.0 gr Agaricus bisporus powder per
day. The control group will receive placebo capsules containing maltodextrin of
which the participants will also need to take 10 per day. Both capsules have
the same shape and look identical. The capsules will be consumed divided over
the day with the main meals.
Study burden and risks
: Subjects will be screened via telephone to determine eligibility. If a
subject fulfills all criteria, a baseline visit is planned where the informed
consent is obtained at the start. If the consent form is signed, a baseline
blood sample will be taken and subjects will start consuming the active or
placebo capsules until their influenza vaccination. This means that the time
period between the start of consuming the Agaricus bisporus powder and the
actual vaccination might slightly differ between participants, but the targeted
period for consumption of the capsules is at least 4 weeks prior to the
receiving the vaccination. Volunteers will be asked to visit the university for
a second fasting blood sample the day before the vaccination. Following the
influenza vaccination, study participants will continue to consume the capsules
and will visit the university weekly for 4 additional weekly blood samples
during the next 4 weeks. The 10 capsules will be consumed divided over the day
as part of three main meals. There are no direct benefits for study subjects.
The intervention and control capsules are considered to be safe. Some study
subjects may report pain and/or a hematoma during or after the venipuncture.
Subjects that do not fully adhere to the study protocol will be excluded from
analyses in the per protocol analysis while be included in the
intention-to-treat analysis. Time investment per participant will be
approximately 4 hours in total, without considering any estimated travel time.
The total blood sampling volume over the entire study period will be
approximately 85 mL.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Aged 60 years or older during influenza season 2023/2024 (in line with RIVM
guidelines)
BMI between 20 and 35 kg/m2
Willing to abstain from mushrooms other than the capsules containing a mushroom
powder as provided by us during the study period.
Willing to keep the intake of fish oil, Zinc, Selenium and (vitamin)
supplements constant
Willing to abstain from products / supplements enriched with Vitamin D
Willing to abstain from products / supplements enriched with plant sterols or
stanols
Willing to abstain from products / supplements enriched with (β)glucans or
fungi.
Willing to abstain from products / supplements that are mentioned to *boost
your immune system*
Willing to abstain from (products enriched in) pre/pro-biotics
Exclusion criteria
Already received influenza vaccination in 2023
Allergy to mushrooms
Known allergic reaction to an active component or other components of the
vaccine (e.g. Chicken Eggs)
Having donated blood within one month prior to the start of the study, or
planning to donate blood during the study
Excessive alcohol use (>20 consumptions per week)
Regular use of soft and/or hard drugs
Using medication for diseases known to affect inflammation/immunity (e.g.
inhaled corticosteroids and prednisone)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Na METC goedkeuring wordt het in ClinicalTrials.gov geregistreerd |
| CCMO | NL84275.068.23 |